Aclaris Therapeutics : Investor Presentation - January 2025

Published: 2025-01-13 09:05:13 ET ACRS

I N V E S T O R

P R E S E N T A T I O N

Corporate Overview

January 2025

Biotechnology Company Focused on Immuno-inflammatory Diseases with Large and Small Molecule Therapeutics

All with best-in-class potential and proven biology

Innovative Pipeline

(investigational drug candidates)

World Class Expertise/Capability

Rich Catalyst Calendar

ATI-045- monoclonal antibody targeting thymic stromal lymphopoietin (TSLP)

ATI-052- bispecific antibody targeting both TSLP and interleukin-4 receptor (IL4R)

ATI-2138- oral inhibitor of ITK/JAK3

ITK inhibitor - oral selective ITK inhibitor

Small and large molecule discovery and development expertise - leadership with over a

dozen biologics approved, and over 30 small molecules advanced into clinical development and 6 small molecules approved

Proprietary kinase small molecule discovery engine complemented by in-house multidisciplinary scientific team

Strong balance sheet is expected to fund company into 2028

Cash runway is expected to fund

multiple catalysts per year

Additional catalysts expected from the development of ATI-045in severe asthma and CRSwNP by China partner

CRSwNP - Chronic Rhinosinusitis with Nasal Polyps

Experienced Leadership Team

DR. NEAL WALKER

Interim CEO &

Chairman

25+ years life sciences experience

Successful serial entrepreneur; founder and leader of several life science companies

Board certified Dermatologist

JOE MONAHAN, PHD

Chief Scientific

Officer

35+ years pharmaceutical research experience

Lead Founder and Former CSO of Confluence Life Sciences

Former Pfizer Leader of Global Kinase Team

HUGH DAVIS, PHD

President and Chief

Operating Officer

35+ years in biologics development, clinical pharmacology, and business development

Former roles at Frontage, GSK and Johnson & Johnson

Key team member for approval of REMICADE®,

STELARA®, DARZALEX®

STEVEN KNAPP, PHARMD

EVP, Head of Regulatory & Quality

35+ years experience in in regulatory and quality

Former roles at Antares, Valeant and BMS

Key team member for approval of ERBITUX®

JAMES LOEROP

Chief Business

Officer

30+ years of large pharma and biotech BD experience

Former Business Development leadership roles at Alexion, GSK. Stifel Laboratories and Anika Therapeutics

KEVIN BALTHASER

Chief Financial

Officer

14+ years of financial leadership including over 10 years in the life sciences industry

Former accounting and finance roles at Lannett Company and PwC

Certified Public Accountant

Broad Immunology Development Pipeline

PRECLINICAL

PHASE 1

PHASE 2

PHASE 3

PARTNER

ATI-045

Severe Asthma

CTTQ (China)

TSLP mAb

Chronic Rhinosinusitis

Subcutaneous

CTTQ (China)

with Nasal Polyps

Atopic Dermatitis

(moderate-to-severe)

COPD

CTTQ (China)

ATI-2138

Atopic Dermatitis

ITK/JAK3 Inhibitor

(moderate-to-severe)

Oral

ATI-052

TSLP x IL4R BsAb Respiratory/

SubcutaneousDermatology

Undisclosed

ITK Selective Inhibitor

Autoimmune

Oral

Lepzacitinib (ATI-1777)

Atopic Dermatitis

JAK1/JAK3 Inhibitor

Pediatrix (China)

(moderate-to-severe)

Soft Topical

ATI-045: Anti-TSLP Monoclonal Antibody Program

Investigational Drug Candidate

TSLP Overview

• ATI-045 (Bosakitug) is a humanized monoclonal antibody targeting thymic stromal lymphopoietin (TSLP)

• TSLP - Pleiotropic and broad activity

OX40L

- Master regulator of type 2 (Th2) immune

responses at the barrier surfaces of skin and

the respiratory/ gastrointestinal tract

Adapted from Int J Mol Sci. 2021 Apr 22;22(9):4369

ATI-045 Unique Differentiation

Best-in-Class Potential

ATI-045 Key Properties

60x More Potent than Tezepelumab

>60x hPBMC CCL17 Inhibition

mean % stim, R&D TSLP @ 0.1ng/mL

120

100

60 IC50

ATI-045

Tezepelumab

Antibody (nM)

Human TSLP

ka (1/Ms)

kd (1/s)

KD (M)

2.16E+06

<1E-05*

<4.63E-12*

Data on file

* Quantification of dissociation rate limited by the surface plasmon resonance instrument sensitivity

Dissociation Kinetics and Residence Time

Dissociation of TSLP from mAbs (TR-FRET)

Residence Time

Fractional Response (yi/yo)

1.0

0.5

0.0

1000

2000

3000

4000

Time (min)

ATI-045

ATI-052

GSK-5784283

(hu3-13)*

GSK-5784283

(hu179-33)*

Solrikitug/MK-8226**

Tezepelumab**

(hours)

TSLP

TSLPR1

(n=3)

(n=2)

416

402

14.3

8.11

22.1

3.59

20.7

ATI-052

ATI-045

Tezepelumab**

Solrikitug/MK-8226**

GSK-5784283 V2 (hu179-33)*

GSK-5784283 V1 (hu3-13)*

UPB-101

ATI-045 and ATI-052 demonstrate very slow dissociation kinetics from TSLP relative to comparator antibodies

The residence time for ATI-045 and ATI-052 is ~20-100x longer than comparator antibodies

Data on file

1. SPR: Residence Time based on apparent kd using standard TSLPR immobilization density and bivalent fit; *Analog mAb; **Biosimilar mAb

ATI-045 Has Greater Potency Than Other TSLP/TSLPR Antibodies

TSLP Stimulated CCL17 Production from hPBMC

IC50 (XΔ) vs ATI-045

140

120

100

0.1ng/ml TSLP

ATI-052

ATI-045

Tezepelumab*

hu3-13 (GSK-5784283 v1)**

UPB-101 (Verekitug anti-TSPLR)*

MK-8226 (Solikritug)*

hu179-33 (GSK-5784283 v2)**

Antibody (nM)

ATI-045

ATI-052

hu179-33 (GSK2)**

MK-8226*

UPB-101*

hu3-13 (GSK1)**

Tezepelumab*

70X

ATI-045 is the most potent of the TSLP/TSLPR antibodies evaluated in blocking CCL17 production

The bifunctional antibody, ATI-052, retains much of the potency for TSLP functional blockade compared with the parent ATI-045

Data on file

*Biosimilar; **Analog

Disclaimer

Aclaris Therapeutics Inc. published this content on January 13, 2025, and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on January 13, 2025 at 14:04:06.085.